The Effect of a Magic Show Featuring "Kuco" on Pain and Fear Experienced During an Invasive Procedure
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Procedure-Related Pain
研究概览
简要总结
Children frequently experience pain and fear during invasive procedures such as venipuncture and peripheral intravenous catheter insertion. These experiences may negatively affect children's cooperation during procedures and increase anxiety related to future healthcare encounters. Non-pharmacological distraction techniques are recommended to reduce procedure-related pain and fear in pediatric patients.
This randomized controlled trial aims to evaluate the effect of a standardized magic show featuring "Kuco" on pain and fear experienced by children during invasive procedures. Eighty children aged 5-8 years who require venipuncture or peripheral intravenous catheter insertion will be randomly assigned to either an intervention group or a control group. Children in the intervention group will receive a standardized magic show performed with the "Kuco" puppet before and throughout the invasive procedure, whereas children in the control group will receive routine clinical care only.
Pain and fear will be assessed immediately before and after the procedure using the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale. The findings are expected to provide evidence regarding the effectiveness of a magic show-based distraction intervention for reducing procedure-related pain and fear in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 5 to 8 years.
- •Requiring venipuncture or peripheral intravenous catheter insertion in the pediatric emergency department, pediatric blood collection unit, or pediatric day-care unit.
- •Able to communicate in Turkish.
- •Conscious and able to respond to the study scales.
- •No visual or hearing impairment that would interfere with participation in the intervention or outcome assessment.
- •Parent or legal guardian provides written informed consent, and the child provides assent when appropriate.
排除标准
- •Presence of a chronic psychiatric or neurological disorder.
- •Presence of a severe chronic medical condition that may affect pain or fear perception.
- •Administration of analgesic, sedative, or anxiolytic medication before the procedure.
- •Previous participation in this study.
- •Child or parent refuses to participate or withdraws consent at any stage of the study.
- •Failure to complete the invasive procedure or the study assessments.
研究组 & 干预措施
Magic Show Intervention
Participants in this arm will receive a standardized magic show featuring the "Kuco" puppet before and throughout the invasive procedure (venipuncture or peripheral intravenous catheter insertion), in addition to routine clinical care. The intervention is designed as a non-pharmacological distraction technique to reduce procedure-related pain and fear.
干预措施: Kuco Magic Show (Behavioral)
Control
Participants in this arm will receive routine clinical care during venipuncture or peripheral intravenous catheter insertion without any additional distraction intervention.
结局指标
主要结局
Procedure-Related Pain
时间窗: Immediately before and within 1 minute after the invasive procedure.
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale immediately before and within 1 minute after the invasive procedure. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity.
Procedure-Related Fear
时间窗: Immediately before and within 1 minute after the invasive procedure.
Fear will be assessed using the Children's Fear Scale immediately before and within 1 minute after the invasive procedure. The scale ranges from 0 to 4, with higher scores indicating greater fear.
次要结局
未报告次要终点
研究者
Abdullah Sarman
Associate Professor
Bingol University